2.
"For the duty to warn to exist, the use of the product
must be foreseeable to the manufacturer or seller." Syl.
Pt. 3, Ilosky v. Michelin Tire Corp., 172 W.Va. 435,
307 S.E.2d 603 (1983).

3.
"In order to establish a prima facie case of
negligence in West Virginia, it must be shown that the
defendant has been guilty of some act or omission in
violation of a duty owed to the plaintiff. No action for
negligence will lie without a duty broken." Syl. Pt. 1,
Parsley v. Gen. Motors Acceptance Corp., 167 W.Va.
866, 280 S.E.2d 703 (1981).

4.
There is no cause of action in West Virginia for failure to
warn and negligent misrepresentation against a brand-name
drug manufacturer when the drug ingested was produced by a
generic drug manufacturer.

OPINION

LOUGHRY JUSTICE.

This
matter is before this Court upon a June 9, 2017, order of the
United States Court of Appeals for the Fourth Circuit
certifying the following question:

Whether West Virginia law permits a claim of failure to warn
and negligent misrepresentation against a branded drug
manufacturer when the drug ingested was produced by a generic
manufacturer.

By
order dated August 30, 2017, this Court accepted the
certified question and docketed the matter for
resolution.[1] Upon review of the parties'
briefs, arguments, the appendix record, and the pertinent
law, we answer the certified question in the
negative.[2]

I.
Regulatory Background

We
begin our analysis with a brief discussion of federal
prescription drug regulations to provide the necessary
background for addressing the question before us. A
manufacturer seeking federal approval to market a new drug in
interstate commerce must prove that the drug is safe and
effective and that the manufacturer's proposed label is
accurate and adequate. PLIVA, Inc. v. Mensing, 564
U.S. 604, 612 (2011) (citations and footnote omitted). The
United States Supreme Court has explained the approval of a
new prescription drug as follows:

In the case of a new brand-name drug, FDA approval can be
secured only by submitting a new-drug application (NDA). An
NDA is a compilation of materials that must include full
reports of all clinical investigations, relevant nonclinical
studies, and any other data or information relevant to an
evaluation of the safety and effectiveness of the drug
product obtained or otherwise received by the applicant from
any source. The NDA must also include the labeling proposed
to be used for such drug and a discussion of why the
drug's benefits exceed the risks under the conditions
stated in the labeling. The FDA may approve an NDA only if it
determines that the drug in question is safe for use under
the conditions of use prescribed, recommended, or suggested
in the proposed labeling thereof. In order for the FDA to
consider a drug safe, the drug's probable therapeutic
benefits must outweigh its risk of harm.

The process of submitting an NDA is both onerous and lengthy.
A typical NDA spans thousands of pages and is based on
clinical trials conducted over several years.

In
1984, Congress enacted the Drug Price Competition and Patent
Term Restoration Act, which is commonly known as the
Hatch-Waxman Act ("Hatch-Waxman" or "the
Act"), in order to get prescription drugs to market in a
speedier and less expensive manner. Abbott Labs. v.
Young,920 F.2d 984, 985 (D.C. Cir. 1990). The Act was
also intended to improve the affordability of prescription
drugs while encouraging innovation of new drugs. Id.
Under the Act, generic drugs can gain approval of the Federal
Food and Drug Administration ("FDA") merely by
showing equivalence to a brand-name drug that has already
been approved by the FDA. Mensing, 564 U.S. at 612.
Specifically, once the patent expires on a brand-name drug, a
pharmaceutical company seeking to market a generic version of
the drug can submit an "Abbreviated New Drug
Application" ("ANDA") which requires the
following:

First, the proposed generic drug must be chemically
equivalent to the approved brand-name drug. It must have the
same active ingredient or active ingredients, route of
administration, dosage form, and strength as its brand-name
counterpart. Second, a proposed generic must be bioequivalent
to an approved brand-name drug. That is, it must have the
same rate and extent of absorption as the brand name drug.
Third, the generic drug manufacturer must show that the
labeling proposed for the new drug is the same as the
labeling approved for the [approved brand-name] drug.

Bartlett, 570 U.S. at 479 (quotations marks and
citations omitted). Further, generic manufacturers are
prohibited from making any unilateral changes to their drug
labels once those labels have been approved by the FDA, and
they may alter a warning label only when necessary to
duplicate a change in a brand-name label or to follow the
FDA's instructions.[3]See Mensing, 564 U.S. at
613-615.[4] The Supreme Court has characterized
the fact that generic drug labels must match brand-name drug
labels as an "ongoing federal duty of
'sameness.'" Mensing, 564 U.S. at 613
(citations omitted). In return for granting generic drugs an
expedited path to approval, Hatch-Waxman authorized the FDA
to extend the length of brand-name manufacturers' patents
for a period of up to five years, depending on the length of
the review period, so that brand-name manufacturers have a
monopoly over their newly-developed drugs for a longer period
of time. Sergeants Benevolent Assoc. Health and Welfare
Fund, Nos. 15-cv-6549, 15-cv-7488, 2016 WL 4992690, at
*3 (S.D.N.Y. Sept. 13, 2016).

In
2009, the United States Supreme Court held in Wyeth v.
Levine, 555 U.S. 555 (2009), that, generally, plaintiffs
may bring state failure-to-warn claims against manufacturers
of brand-name drugs. The Supreme Court reasoned that such a
claim was not preempted by federal law because it is possible
for a brand-name manufacturer to comply with both state and
federal law under the FDA's regulations. Id. at
573. However, two years later in Mensing, the
Supreme Court determined that federal labeling law for
generic drugs generally preempts state failure-to-warn claims
brought by plaintiffs alleging that manufacturers of generic
drugs failed to warn of the risks of taking its drug.
Mensing, 564 U.S. at 624. The Supreme Court reasoned
that if the generic drug manufacturers had independently
changed their labels to meet state law requirements to attach
a safer label to the drug, the generic manufacturers would
have violated the federal requirement that generic drug
labels must correspond verbatim to brand-name drug labels.
564 U.S. at 618. Thus, concluded the Supreme Court, it is
impossible for the generic drug manufacturers to comply with
both state and federal law. Id. at 624.

This
preemption of state failure-to-warn claims against generic
drug manufacturers has, in the words of the federal district
court in the case at bar,

[c]reated what the Supreme Court has acknowledged as an
"unfortunate" quirk: plaintiffs who ingest a
brand-name drug may well have a cause of action against the
brand-name manufacturer, but those who ingest a generic drug
with the same composition and same label as the brand-name
drug have no similar recourse against the generic
manufacturer.

McNair v. Johnson & Johnson, No. 2:14-17463,
2015 WL 3935787, at *4 (S.D.W.Va. June 26, 2015) (citing
Mensing, 564 U.S. at 625) (indicating that
"[h]ad [plaintiffs] taken Reglan, the brand-name drug
prescribed by their doctors . . . their lawsuits would not be
preempted. But because pharmacists, acting in full accord
with state law, substituted generic metoclopramide instead,
federal law pre-empts these lawsuits." (additional
citation omitted)). We now turn to the specific facts of this
case.

II.
Facts and Procedural Background

The
petitioners, the McNairs, filed an action in the Circuit
Court of Kanawha County against the respondent, Janssen
Pharmaceuticals ("Janssen"), alleging that in March
2012, Mrs. McNair developed acute respiratory distress
("ARDS") after ingesting the generic drug
levofloxacin[5] that was manufactured by Dr.
Reddy's Laboratories Limited ("Dr.
Reddy's"). Janssen originally trademarked and sold
levofloxacin under the brand Levaquin®. Thus, Janssen
produced the warnings on the label that accompanied the
distribution of Levaquin, which were subsequently used by
generic manufacturers of levofloxacin. The McNairs alleged in
their complaint that Janssen was aware that ARDS had been
linked to the use of levofloxacin but negligently failed to
include a warning, knowing this omission would exist not only
in its distribution of Levaquin, but also in the warnings
accompanying generic versions of the drug. Asserting several
products liability claims, the McNairs' general theory of
liability is that even though Mrs. McNair took a generic
version of the drug, Janssen had exclusive control of the
content of the warnings that were published to the public and
to health care providers for both the brand-name and the
generic forms of the drug. Therefore, the McNairs conclude
that Janssen is liable for their alleged injuries.

Janssen
removed the action to federal court on diversity grounds.
Janssen then moved for summary judgment, arguing that it
could not be liable for a drug it did not manufacture or
distribute because, under West Virginia law, a
manufacturer's culpability in a products liability case
is tied to conduct associated with designing, manufacturing
or selling a defective product. The McNairs conceded that
Janssen did not manufacture or sell the generic drug that
Mrs. McNair ingested, but nonetheless urged the federal
district court to deny Janssen's motion, averring that
Janssen alone made the decision not to warn about ARDS in its
labeling. The McNairs also pointed out that federal law
precluded an action against Dr. Reddy's based on a
failure to warn because the generic manufacturer was
prohibited from changing the warning on its label in any way
from the warning label prepared by Janssen. Finally, the
McNairs argued that granting Janssen's motion would mean
no party is liable for the alleged misinformation that
purportedly caused Mrs. McNair's injury.

The
federal district court granted summary judgment to Janssen.
The district court reasoned that every federal court of
appeals to consider the issue, both before and after
Mensing, has rejected the contention that a
brand-name drug manufacturer's statements regarding its
drug could serve as the basis of liability for injuries
caused by another manufacturer's drug. The district court
observed that in West Virginia, "[p]roduct liability law
. . . allows for recovery when the plaintiff can prove that
'a product was defective when it left the manufacturer
and the defective product was the proximate cause of the
plaintiff's injuries.'" McNair, 2015 WL
3935787, at *6 (citing Meade v. Parsley, No. 09-388,
2009 WL 3806716, at *3 (S.D.W.Va. Nov. 13, 2009) (quoting
Dunn v. Kanawha Co. Bd. of Educ., 194 W.Va. 40, 46,
459 S.E.2d 151, 157 (1995)). The district court found that
because Janssen did not manufacture the product that Mrs.
McNair ingested, there is no proximate cause and no basis on
which to hold Janssen liable. The district court further
ruled that the McNairs' breach of express and implied
warranty claim failed because Janssen did not sell to the
McNairs the product that allegedly injured Mrs. McNair and
made no warranty of any kind regarding the specific product
the McNairs purchased.[6]

The
McNairs appealed the district court's ruling to the
Fourth Circuit Court of Appeals. The Court of Appeals
certified to this Court the question set forth above.

III.
Standard of Review

We have
consistently held that "[a] de novo standard is applied
by this Court in addressing the legal issues presented by a
certified question from a federal district or appellate
court." Syl. Pt. 1, Light v. Allstate Ins. Co.,
203 W.Va. 27, 506 S.E.2d 64 (1998). With this standard to
guide us, we proceed to consider the certified question.

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